Actinic KeratosesPhase 3NCT05662202
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
A Phase 3 study testing BF-200 ALA and red light LED lamp in people with Actinic Keratoses, run by Biofrontera Inc. at 14 sites in United States.
Trial summary
The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- BF-200 ALA and red light LED lamp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 14 sitesUnited States
- Study dates
- 12 Dec 2022to 1 Jul 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- 4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field.
- All sexes, ≥ 18 years of age.
- Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit.
- Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks.
- Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
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- Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the next clinical visit.
- Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase.
- For female subjects with reproductive potential: Negative serum pregnancy test.
- For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study (until Visit 4 or Visit 6).
Who cannot join
- Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA.
- History of soy or peanut allergy.
- Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field.
- Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
- Presence of photodermatoses or porphyria
- Metastatic tumor or tumor with high probability of metastasis
Show all 37Show fewer
- Infiltrating skin neoplasia (suspected or known)
- Unstable cardiovascular disease (New York Heart Association class III, IV)
- Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
- Unstable collagen-vascular condition
- Unstable gastrointestinal condition
- Immunosuppressive condition
- Presence of clinically significant inherited or acquired coagulation defect
- Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (< 2 cm distance) to the treatment field.
- Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
- Any physical therapy such as cryotherapy, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks prior to screening.
- Any of the topical treatments defined below within the designated periods prior to screening:
- Topical treatment with ALA or ALA esters (e.g., methyl aminolevulinic acid (MAL)) inside the treatment field within 3 months.
- Topical treatment with immunomodulatory, cytostatic, or cytotoxic drugs inside or in close proximity (< 10 cm distance) to the treatment field within 3 months.
- Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction.
- Any use of the systemic treatments within the designated periods prior to screening:
- Cytostatic or cytotoxic drugs within 6 months.
- Immunosuppressive therapies or ALA or ALA esters (e.g., MAL) within 12 weeks.
- Drugs known to have major organ toxicity within 8 weeks.
- Interferon or glucocorticosteroids within 6 weeks.
- Start of intake of medication with hypericin or drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction.
- Breast feeding women.
- Suspicion of drug or alcohol abuse.
- Subjects unlikely to comply with protocol, e.g., inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator.
- A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
- Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study.
- Reassessment of subjects is allowed once in case exclusion criterion 3 is met and eligibility can be achieved within 4 weeks. Reassessment can be done on the day of the actual treatment.
- Dosing day exclusion criteria:
- At Visit 2 (baseline, PDT-1)
- Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within 2 weeks.
- At Visit 4 (PDT-2)
- Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Rescheduling of PDT-2 can be performed once at the earliest possibility after resolution, but rescheduling should not exceed 2 weeks.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
DermResearch, P.A.
Austin, Texas, 78759
DelRicht Research
Baton Rouge, Louisiana, 70809
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Associates PA of the Palm Beaches
Delray Beach, Florida, 33445
Dermatology Practice
Greenwood Village, Colorado, 80111
Austin Institute for Clinical Research
Houston, Texas, 77056
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, 46260
Austin Institute for Clinical Research Inc.
Pflugerville, Texas, 78660
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Alliance Dermatology & Mohs Center
Phoenix, Arizona, 85032
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Rochester Dermatologic Surgery
Victor, New York, 14564
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
- Conditions
- Actinic Keratoses
- Being tested
- BF-200 ALA and red light LED lamp, Vehicle and red light LED lamp
- Keywords
- Actinic keratosis, Photodynamic therapy, 5-aminolevulinic acid, Photosensitizing Agents
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-200 ALA and red light LED lampCombination product
Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT):
Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.
PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.
Vehicle and red light LED lampCombination product
Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT):
Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.
PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.
| Study group | Role | What they receive |
|---|---|---|
| BF-200 ALA | Experimental | Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT) Receives: Combination Product: BF-200 ALA and red light LED lamp |
| Vehicle | Placebo comparator | Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT) Receives: Combination Product: Vehicle and red light LED lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Subject Complete Response Rate
Percentage of subjects with all AK target lesions clinically cleared after last PDT
Measured: 12 weeks after the last PDT (Visit 4 or Visit 6)
Secondary outcomes (17)
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Extremities
Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT
Measured: 12 weeks after the last PDT (Visit 4 or Visit 6)
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Neck/Trunk
Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT
Measured: 12 weeks after the last PDT (Visit 4 or Visit 6)
Lesion Complete Response Rate
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen).
Measured: 12 weeks after the last PDT (Visit 4 or Visit 6)
Complete Response Rate for Severe Lesions
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area.
Measured: 12 weeks after the last PDT (Visit 4 or Visit 6)
Subject Complete Response Rate After PDT-1
Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters.
Measured: 12 weeks after PDT-1 (Visit 4)
Lesion Complete Response Rate After PDT-1
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen [mild, moderate, severe]).
Measured: 12 weeks after PDT-1 (Visit 4)
Complete Response Rate for Severe Lesions After PDT-1
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen [mild, moderate, severe]; Visit 2) after PDT-1, overall and stratified by treatment area.
Measured: 12 weeks after PDT-1 (Visit 4)
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
The esthetic appearance after the last PDT as assessed by the investigator according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
Measured: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
Measured: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Satisfaction With PDT at the End of Treatment Phase
Satisfaction with PDT treatment after the last PDT as assessed by the subject; overall and stratified by treatment area. Therefore, subjects were asked if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no).
Measured: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area.
TEAEs were defined as all AEs starting with or after IMP application and within 12 weeks (+ 7 days) after the last PDT, or as related AEs (possibly, probably, or definitely related, or with missing relationship) occurring more than 12 weeks after the last PDT.
Measured: During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New Lesions Inside the Treatment Field During Treatment Phase
New lesions: AK, non-melanoma skin cancer [NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)] or melanoma
Measured: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Assessment of Application Site Reactions
Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) were assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe. The worst severity across all assessment timepoints and illumination areas is presented.
Measured: All visits (except screening, Visit 1) throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Application Site Pain During Illumination
Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area. The maximum of pain score over all illuminations is shown.
Measured: During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)
Number of Patients With Significant Changes of Vital Signs
Number of patients with changes in blood pressure (systolic and diastolic) [mmHg] and changes in pulse rate [beats/min]. Findings which differed from reference range and were considered clinically significant were to be reported.
Measured: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Significant Changes in Safety Laboratory
Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differed from reference range and were considered clinically significant were to be reported.
Measured: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Abnormal Findings in Physical Examination
Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status were to be performed. Abnormal findings considered clinically significant were to be reported.
Measured: At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start12 Dec 2022
- Primary completion3 Sep 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofrontera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathalie Zeitouni, MD, Principal investigator, Medical Dermatology Specialists; Phoenix, Arizona, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662202
- Sponsor's protocol ID
- ALA-AK-CT019
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2022
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
- ClinicalTrials.gov ID
- NCT05662202
- Acronym / sponsor ID
- ALA-AK-CT019
- Conditions
- Actinic Keratoses
- Keywords
- Actinic keratosis, Photodynamic therapy, 5-aminolevulinic acid, Photosensitizing Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Biofrontera Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-200 ALA | Experimental | Combination Product: BF-200 ALA and red light LED lampTopical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride). Red light photodynamic therapy (PDT) |
| Vehicle | Placebo comparator | Combination Product: Vehicle and red light LED lampTopical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- 4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field.
- All sexes, ≥ 18 years of age.
- Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit.
- Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks.
Key exclusion criteria (37 listed)
- Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA.
- History of soy or peanut allergy.
- Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field.
- Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
- Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (< 2 cm distance) to the treatment field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BF-200 ALA and red light LED lampUp to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT): Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit. | Combination product | BF-200 ALA |
| Vehicle and red light LED lampUp to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT): Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit. | Combination product | Vehicle |
Primary outcome
Overall Subject Complete Response Rate
Time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions clinically cleared after last PDT
17 secondary outcomes
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Extremities
Time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Neck/Trunk
Time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)
Lesion Complete Response Rate
Time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)
Complete Response Rate for Severe Lesions
Time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)
Subject Complete Response Rate After PDT-1
Time frame: 12 weeks after PDT-1 (Visit 4)
Lesion Complete Response Rate After PDT-1
Time frame: 12 weeks after PDT-1 (Visit 4)
Complete Response Rate for Severe Lesions After PDT-1
Time frame: 12 weeks after PDT-1 (Visit 4)
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Time frame: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Time frame: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Satisfaction With PDT at the End of Treatment Phase
Time frame: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
Time frame: During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New Lesions Inside the Treatment Field During Treatment Phase
Time frame: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Assessment of Application Site Reactions
Time frame: All visits (except screening, Visit 1) throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Application Site Pain During Illumination
Time frame: During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)
Number of Patients With Significant Changes of Vital Signs
Time frame: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Significant Changes in Safety Laboratory
Time frame: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Abnormal Findings in Physical Examination
Time frame: At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Zeitouni, MD principal investigator
Medical Dermatology Specialists; Phoenix, Arizona, United States
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BF-200 ALA and red light LED lamp in people with Actinic Keratoses, run by Biofrontera Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Subject Complete Response Rate (time frame: 12 weeks after the last PDT (Visit 4 or Visit 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.